Chorioamnionitis, Neonatal Early Onset Sepsis, Neonatal Meningitis, Neonatal Pneumonia, Puerperal Endometritis
Conditions
Keywords
premature rupture of membranes, term pregnancy, chorioamnionitis, endometritis, neonatal sepsis, antibiotic prophylaxis
Brief summary
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (\< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.
Interventions
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
Sponsors
Hospital de Santa Maria, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* term (≥ 37+0 weeks) singleton pregnancy * a vertex presentation * ruptured membranes for less than 12 hours * negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks
Exclusion criteria
* active labor * absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis) * contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neonatal infection rate | participants will be followed for the duration of hospital stay, an expected average of 3 days | neonatal infection rate includes early onset sepsis, meningitis and pneumonia |
| maternal infection rate | participants will be followed for the duration of hospital stay, an expected average of 3 days | maternal infection rate includes chorioamnionitis or puerperal endometritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of the infection rates between prompt and delayed induction | participants will be followed for the duration of hospital stay, an expected average of 3 days | rate of maternal and neonatal infection between prompt (\<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis |
Countries
Portugal
Outcome results
None listed